A Study of MHAA4549A as Monotherapy for Acute Uncomplicated Seasonal Influenza A in Otherwise Healthy Adults

NCT02623322 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: GV298932016-000425-40
• Study Type: interventional
• Target: 124
• Locations: 7 countries
• Sites: 80

Brief Summary

This is a Phase 2, randomized, double-blind, placebo-controlled single dose study in otherwise healthy adults with acute uncomplicated seasonal influenza A to assess the safety and tolerability, efficacy, and pharmacokinetics of MHAA4549A.

Conditions

Influenza A

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events (AEs)

  An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.

  Baseline to Day 100

Secondary Outcomes (9)

• Percentage of Participants Requiring Hospitalization for Influenza-Related Complications

  Baseline to Day 100

• Duration of Hospitalization for Influenza-Related Complications

  Baseline to Day 100

• Percentage of Participants Requiring Antibiotics for Secondary Bacterial Respiratory Infections

  Baseline to Day 100

• Percentage of Participants With Complications of Influenza

  Baseline to Day 100

• Percentage of Participants With Influenza A Relapse/Reinfection

  Baseline to Day 100

Study Arms (3)

MHAA4549A 3600 milligrams (mg)

EXPERIMENTAL

Participants will receive single-dose MHAA4549A, 3600 mg, by intravenous (IV) administration.

Drug: MHAA4549A

MHAA4549A 8400 mg

EXPERIMENTAL

Participants will receive single-dose MHAA4549A, 8400 mg, by IV administration.

Drug: MHAA4549A

Placebo

PLACEBO COMPARATOR

Participants will receive single-dose placebo by IV administration.

Drug: Placebo

Interventions

MHAA4549A DRUG

MHAA4549A will be administered as a single dose by IV administration.

MHAA4549A 3600 milligrams (mg); MHAA4549A 8400 mg

Placebo DRUG

Placebo will be administered as a single dose by IV administration.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Otherwise healthy participants
• Positive test for influenza A infection
• No more than 72 hours elapsed between onset of influenza-like illness and start of study drug
• Presence of at least one moderate or severe constitutional symptom such as headache, myalgia, fever, chills, fatigue, anorexia, or nausea PLUS one moderate or severe respiratory symptom such as cough, sore throat, or rhinorrhea
• For women of childbearing potential: negative pregnancy test and agreement to use acceptable contraceptive methods for at least 120 days after study drug administration
• For men: agreement to use acceptable contraceptive methods for at least 30 days after study drug administration

You may not qualify if:

• Creatinine clearance less than or equal to (\</=) 80 milliliters per minute (mL/min)
• Any significant medical conditions or laboratory abnormalities
• Clinical signs and symptoms consistent with otitis, bronchitis, sinusitis, or pneumonia or active bacterial infection
• Use of antiviral therapy in the period from onset of influenza-like illness and prior to enrollment
• Pregnancy at Screening or is currently pregnant or breastfeeding
• Investigational therapy within 30 days or 5 half-lives prior to start of study drug, whichever is greater
• Prior anti-influenza monoclonal antibody use
• Receipt of a nasal influenza A vaccine within 14 days prior to Screening
• Positive test for influenza B or influenza A+B within 2 weeks prior to study drug
• History of significant tobacco use or drug/alcohol abuse
• Chronic use of oral or inhaled corticosteroids within 30 days prior to Screening
• Autoimmune disease, known immunodeficiency of any cause, or use of immunosuppressive medications
• History of any chronic respiratory condition
• Human immunodeficiency virus (HIV) with cluster of differentiation (CD) 4 count \</= 200 cells per milliliter (cells/mL) in the past 12 months
• Serious infection requiring oral or IV antibiotics within 14 days prior to Screening

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (80)

North Alabama Research Center LLC

Athens, Alabama, 35611, United States

Location

WCCT Global, LLC

Costa Mesa, California, 92626, United States

Location

Lalla-Reddy Medical Corporation

Fountain Valley, California, 92708, United States

Location

IMMUNOe Research Centers

Centennial, Colorado, 80112, United States

Location

Integrity Clinical Research

Doral, Florida, 33166, United States

Location

Riverside Clinical Research

Edgewater, Florida, 32132, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

The Community Research Of South Florida

Hialeah, Florida, 33016, United States

Location

Innovative Clinical Research, Inc.

Lauderhill, Florida, 33319, United States

Location

South Florida Research Center, Inc.

Miami, Florida, 33135, United States

Location

Oceane7 Clinical Research

Miami, Florida, 33144, United States

Location

Central Florida Internists

Saint Cloud, Florida, 34769, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Advanced Research Institute, Inc.

Trinity, Florida, 34655, United States

Location

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66606, United States

Location

Professional Research Network of Kansas

Wichita, Kansas, 67205, United States

Location

Heartland Research Associates

Wichita, Kansas, 67207, United States

Location

Kentucky Lung Clinic

Hazard, Kentucky, 41701, United States

Location

MedPharmics

Metairie, Louisiana, 70006, United States

Location

Acadiana Medicine Clinic

Opelousas, Louisiana, 70570, United States

Location

Anne Arundel Medical Center; Anne Arundel Health System

Annapolis, Maryland, 21401, United States

Location

UMASS Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Detroit Medical Center

Detroit, Michigan, 48201, United States

Location

Sinai Grace Hospital

Detroit, Michigan, 48235, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63108, United States

Location

Mercury Street Medical Group

Butte, Montana, 59701, United States

Location

Barrett Clinic, P.C.

La Vista, Nebraska, 68128, United States

Location

Global Medical Institutes, LLC

Princeton, New Jersey, 08540, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Center For Medical Research LLC

Providence, Rhode Island, 02908, United States

Location

Emergency MD

Boiling Springs, South Carolina, 29316, United States

Location

HCCA Clinical Research Solutions

Franklin, Tennessee, 37067, United States

Location

Clinical Research Solutions PC

Knoxville, Tennessee, 37920, United States

Location

Clinical Research Solutions, LLC

Smyrna, Tennessee, 37167, United States

Location

University of Texas Medical Branch at Galveston

Galveston, Texas, 77555, United States

Location

Centex Studies

Houston, Texas, 77058, United States

Location

Centex Studies

Pharr, Texas, United States

Location

Manna Research Vancouver

Vancouver, British Columbia, V6J 1S3, Canada

Location

Moncton Hospital

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Manna Research

Toronto, Ontario, M9W 4L6, Canada

Location

Q and T Research

Gatineau, Quebec, J8Y 6S9, Canada

Location

inVentiv Health Clinique

Québec, G1P 0A2, Canada

Location

Henderson Medical Centre

Auckland, 0612, New Zealand

Location

Optimal Clinical Trials

Auckland, 1010, New Zealand

Location

RMC Medical Research Ltd

Dunedin, New Zealand

Location

Tauranga Hospital

Tauranga, 3143, New Zealand

Location

Johese Clinical Research

Centurion, 1692, South Africa

Location

Durban International Clinical Research Site

Durban, 4052, South Africa

Location

Vawda Z Private Practice

Durban, 4091, South Africa

Location

Dr Peter John Sebastian; Dr PJ Sebastian

Durban, 4092, South Africa

Location

Into Research; Life Groenkloof Hospital Medical Centre

Groenkloof, 0181, South Africa

Location

Worthwhile Clinical Trials

Johannesburg, 1500, South Africa

Location

Newtown Clinical Research

Johannesburg, 2113, South Africa

Location

Clinresco Centres (Pty) Ltd

Kempton Park, 1619, South Africa

Location

Peermed Clinical Trial Centre

Kempton Park, 1619, South Africa

Location

Klerksdorp /Tshepong Hospital Complex

Klerksdorp, 2574, South Africa

Location

DJW Navorsing

Krugersdorp, 1739, South Africa

Location

I Engelbrecht Research

Lyttleton, 0157, South Africa

Location

Syzygy Clinical Research; Unit 3 to 7

Pretoria Gauteng Province, 0087, South Africa

Location

Jongaie Research

Pretoria West, 0183, South Africa

Location

Queenswood CTC

Queenswood, 0121, South Africa

Location

Wits Clinical Research

Soweto, 2013, South Africa

Location

Welkom Clinical Trial Centre

Welkom, 9460, South Africa

Location

Hallym University Sacred Heart Hospital

Anyang-si, 14068, South Korea

Location

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, 420-767, South Korea

Location

Gachon University Gil Hospital

Incheon, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, 07441, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Wonju Christian Hospital

Wŏnju, 220-701, South Korea

Location

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07010, Spain

Location

Hospital Mutua de Terrassa; Servicio de Oncologia

Terrassa, Barcelona, 08221, Spain

Location

Hospital San Pedro

Logroño, La Rioja, 26006, Spain

Location

Hospital de Galdakao

Galdacao, Vizcaya, 48960, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Surrey Clinical Research Centre; University of Surrey

Guildford, GU2 7XP, United Kingdom

Location

Barts and the London NHS Trust.

London, EC1A 7BE, United Kingdom

Location

The James Cook University Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

MeSH Terms

Interventions

gedivumab

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

global.trial_information@roche.com

(+41) 616878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 7, 2015
• Study Start: October 12, 2016
• Primary Completion: November 13, 2017
• Study Completion: November 13, 2017
• Last Updated: January 8, 2019
• Results First Posted: January 8, 2019

Record last verified: 2018-12

Locations

NZ (4); ZA (17); CA (5); KR (7); ES (6); GB (3); US (38)